BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 5240322 · Received November 20, 2015

    Report

    Report Number
    3006851902-2015-00002
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 20, 2015
    Report Date
    November 19, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    IQK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTRODUCTION: ON (B)(4) 2015, THREE COMPLAINTS (B)(4) FILED BY THE SAME USER FACILITY ((B)(6)) FOR EMT SELECT EXTRICATION COLLARS BREAKING AT THE BLUE COLLAR PIECE. EACH COMPLAINT LISTED ONE INDIVIDUAL EMT COLLAR AND A CORRESPONDING LOT NUMBER. IN ADDITION TO FILING THE THREE COMPLAINTS LISTED, THE USER FACILITY ALSO FILED ONE MEDWATCH REPORT ((B)(4)) FOR THE SAME THREE INCIDENTS. IT WAS VERBALLY VERIFIED BY THE INVESTIGATOR WITH THE CONTACT PERSON FROM COMPLAINTS (MS. (B)(6)) THAT THE REFERENCED COMPLAINTS AND THE MEDWATCH REPORT REFER TO THE SAME INCIDENTS. INVESTIGATOR WAS UNABLE TO REACH THE INITIAL REPORTER (MS. (B)(6)) OF THE MEDWATCH REPORT BY PHONE OR EMAIL. ALL THREE COMPLAINTS INVOLVE THE SAME PART WITH THE SAME FAILURE MODE. LISTED BELOW ARE THESE 3 COMPLAINT NUMBERS WITH THE IR CORRESPONDING MDR NUMBER. COMPLAINT 34851 - 3006851902-2015-00001, COMPLAINT 34852 - 3006851902-2015-00002, COMPLAINT 34853 - 3006851902-2015-00003 . BACKGROUND INFORMATION ON THE PRODUCT IN QUESTION. THE PRODUCT 1044-31, EMT SELECT EXTRICATION COLLAR, IS A CLASS 1, 510(K) EXEMPT, GMP EXEMPT, PRODUCT CLASSIFIED UNDER PRODUCT CODE IQK. THE MAIN COMPONENTS OF THIS PRODUCT ARE THREE MOLDED PARTS. THE ADULT CHIN CUP ((B)(4)) AND ADULT FRONT BODY ((B)(4)) PARTS ARE MADE OF MOLDED WHITE POLYPROPYLENE (PP). THE ADULT BODY ((B)(4)) IS MADE OF BLUE MOLDED HIGH DENSITY POLYETHYLENE (HDPE). THIS EXACT SAME PART IS ALSO SOLD UNDER 6 OTHER PART NUMBERS: A111-000, 1044-30, 1044-90, 14-103A-00, 300N10 AND 1117PP. THIS PRODUCT USED TO BE PURCHASED FROM AN OUTSIDE VENDOR. IN 2013, DEROYAL STARTED MANUFACTURING THIS PRODUCT IN-HOUSE. THE PRODUCT AND THE MANUFACTURING PROCESS WERE DESIGNED AT ROYAL PRECISION PLASTICS (RPP) SITE. THE MANUFACTURING PROCESS WAS THEN TRANSFERRED TO AND VALIDATED AT THE DEROYAL (B)(4). INVESTIGATION FINDINGS. COMPLAINT SAMPLE INSPECTION. THERE WERE THREE COMPLAINT SAMPLES AVAILABLE FOR INSPECTION. ONE SAMPLE PER COMPLAINT WAS RECEIVED. EACH SAMPLE WAS BROKEN IN THE SAME WAY AT THE SAME AREA OF THE COLLAR. THE BLUE ADULT BODY PART ((B)(4)) WAS BROKEN ALONG ONE OF THE "RIBS" THAT WOULD NORMALLY BE ON THE NECK. LIST OF COMPLAINT SAMPLES COMPLAINT CALL AND CORRESPONDING LOT NUMBER: COMPLAINT (B)(4) - LOT # 39888983, COMPLAINT (B)(4)- LOT # 39778805, COMPLAINT (B)(4)- LOT # 38588516. EVALUATION OF SIMILAR SAMPLES. INVESTIGATORS COULD NOT TEST THE COMPLAINT SAMPLES, AS THESE WERE ALREADY BROKEN. HOWEVER INVESTIGATORS DID EVALUATE THE OTHER SAMPLES AVAILABLE: PRODUCT SENT BACK FROM USER FACILITY FROM SAME LOTS OF AS THAT OF COMPLAINT SAMPLES. PRODUCT PULLED FROM DEROYAL DISTRIBUTION FACILITY FROM TWO DIFFERENT LOTS (40127348 AND 40131101). WHEN APPLIED AS DIRECTED, INVESTIGATORS WERE UNABLE TO INDUCE A MALFUNCTION. INVESTIGATORS ALSO BENT AND FOLDED THE COLLARS AND WERE UNABLE TO INDUCE THE REPORTED FAILURE. IF HANDLED ROUGHLY ENOUGH, THE SAME MALFUNCTION AS COMPLAINT SAMPLES COULD EVENTUALLY BE INDUCED, IF THE COLLAR WAS BENT OR ROLLED TIGHTLY ENOUGH. IT IS IMPORTANT TO NOTE THAT THIS TYPE OF HANDLING IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE. DETERMINATION OF FAILURE MODE. INVESTIGATORS THEN LOOKED AT HOW THE BLUE PLASTIC PIECE BROKE (FAILURE MODE) WHEN FAILURE WAS INDUCED. ALL THREE COMPLAINT SAMPLES BROKE IN THE EXACT SAME WAY. INVESTIGATORS OBSERVED THAT WHEN A BREAK FAILURE IS INDUCED, IT STARTS AT THE V INTERSECTIONS WHERE 2 RIBS COME TOGETHER IN THE AREA AT THE NECK OF THE BLUE FRONT PIECE. REINFORCING THIS AREA FOR THE COLLAR SHOULD RESULT IN INCREASED ROBUSTNESS TO ACCOUNT FOR WHEN THE COLLAR IS NOT HANDLED AS INTENDED. THIS IS DONE BY MODIFICATION OF THE TOOL USED FOR MOLDING THE PART. ROOT CAUSE: WE WERE UNABLE TO CONFIRM THE ROOT CAUSE SO IT IS CURRENTLY UNKNOWN. A POTENTIAL CAUSE IF USER MISHANDLING OF THE COLLAR. ANOTHER POTENTIAL CAUSE IS THAT THE V INTERSECTIONS WHERE 2 RIBS COME TOGETHER IN THE AREA AT THE NECK NEEDS TO BE REINFORCED IN ORDER TO MAKE UP FOR WHEN THE COLLAR IS NOT HANDLED AS INTENDED. CORRECTIVE ACTIONS. IT IS POSSIBLE TO STRENGTHEN THE AREA WHERE THE BREAKS OCCURRED BY ADDING A RADIUS TO THE RIB JUNCTIONS. REINFORCING THIS AREA FOR THE COLLAR SHOULD RESULT IN INCREASED ROBUSTNESS. PREVENTATIVE ACTIONS. THERE ARE NO PREVENTATIVE ACTION REQUIRED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. -

    Description of Event or Problem · 1

    (B)(4). DATE OF OCCURRENCE: (B)(6) 2015. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. DETAILED DESCRIPTION OF QUALITY ISSUE: WHEN THE EMTS APPLIED THE COLLARS, THE COLLAR SNAPPED IN HALF LEAVING A JAGGED EDGE IN THE FRONT OF THE COLLAR. THESE ARE NOT NEW USERS TO THE COLLARS, THEY WERE ALL SEASONED STAFF AND HAVE USED THE COLLARS FOR AT LEAST 4 YEARS SO I DO NOT BELIEVE IT WAS USER ERROR. PLUS THE FACT THAT IT HAPPENED AT 3 DIFFERENT TIMES, BY 3 DIFFERENT USERS IN 3 DIFFERENT LOCATIONS. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? COLLAR WAS BEING APPLIED TO PATIENTS BY EMTS IN THE FIELD. THREE DIFFERENT END USERS AT DIFFERENT LOCATIONS IN (B)(6). WAS IT THE INITIAL USE OF THE PRODUCT? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770386 DEROYAL EMT SELECT EXTRICATION COLLAR IQK DEROYAL INDUSTRIES, INC. 1044-31 39778805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other